FDG-PET/CT Scans in Patients With Stage IIIB or Stage IV NSCLC Undergoing Chemotherapy
- Conditions
- Lung Cancer
- Registration Number
- NCT00424138
- Lead Sponsor
- American College of Radiology Imaging Network
- Brief Summary
RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18 (\^18FDG) positron emission tomography (PET)/CT scans, may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This clinical trial is studying \^18FDG PET/CT scans to see how well they predict response in patients undergoing chemotherapy for stage IIIB or stage IV non-small cell lung cancer.
- Detailed Description
OBJECTIVES:
* Determine whether a metabolic response, defined as a 25% decrease in peak tumor standardized uptake value (SUV) after the first course of chemotherapy, provides early prediction of treatment outcome (tumor response and patient survival) in patients with stage IIIB or IV non-small cell lung cancer undergoing platinum-based chemotherapy.
* Determine the test-retest reproducibility of quantitative assessment of tumor fludeoxyglucose F 18 (\^18FDG) uptake in these patients.
* Determine the time course of treatment-induced changes in tumor \^18FDG uptake in these patients.
* Determine, in an exploratory analysis, changes in tumor volume during chemotherapy by multislice CT scanning in these patients.
OUTLINE: This is a prospective, multicenter study. Patients are assigned to 1 of 3 groups.
* Group I: Patients undergo fludeoxyglucose F 18 (\^18FDG) positron emission tomography (PET)/CT scanning twice and 1-2 volumetric CT scanning (1-7 days apart) before starting treatment with platinum-based chemotherapy. Patients undergo additional \^18FDG PET/CT scan and a volumetric CT scan once between the first and second course of chemotherapy.
* Group II: Patients undergo \^18FDG PET/CT scan and volumetric CT scanning once before starting treatment with platinum-based chemotherapy. Patients undergo additional \^18FDG PET/CT scan and volumetric CT scanning once between the first and second course of chemotherapy, and may undergo once between the second and third course of chemotherapy.
* Group III: Patients undergo \^18FDG PET/CT scanning twice (up to 1 week apart) before starting any treatment.
In groups I and II, patients also undergo standard follow-up CT scanning every 6 weeks (i.e., every other chemotherapy course) for up to 18 weeks.
After completion of chemotherapy, patients are followed every 3 months for up to 1 year.
Biomarker
* Imaging: See
* provided by American College of Radiology Network.
PROJECTED ACCRUAL: A total of 285 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 96
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Prediction of 1-year overall survival as measured by monitoring changes in tumor metabolic response during the first course of chemotherapy One year
- Secondary Outcome Measures
Name Time Method Correlation of metabolic response after the first course of chemotherapy with progression-free survival 1st Course of Chemotherapy Predictive value of fludeoxyglucose F 18 positron emission tomography (FDG-PET) for 1-year overall survival after the first and second course of chemotherapy One year Test-retest reproducibility of standardized uptake values (SUV) as measured by FDG-PET/CT scans Within 7 Days Correlation of metabolic response after the first course of chemotherapy with subsequent best tumor response as measured by RECIST criteria 1st Course Chemotherapy
Trial Locations
- Locations (1)
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center at UCLA🇺🇸Los Angeles, California, United States